The first court case against Merck, the manufacturers of Vioxx (Rofecoxib) was concluded in Texas, USA on Friday. The jury found that Merck had been negligent and awarded a ¬£140 million settlement. The BBC News website carries more detail.
Merck have already made clear their intention to appeal against this decision as their share price fell by almost 8%. The basis for the appeal appears to be that the patient in question died from cardiac arrhythmia according to the autopsy report and there is no link between Vioxx and this particular heart condition.
The jury are still out and are debating if the cardiac side effects of Cox-IIs is a class effect. It should be noted though that the Summary of Product Characteristics for both Arcoxia (Etoricoxib) and Celebrex (Celecoxib) carry warnings about cardiovascular risks and recommend using the drug, if clinically appropriate, at the lowest possible dose and for the shortest possible duration.
Pfizer are still promoting Celebrex to prescribers with a paper from the Archives of Internal Medicine1 that compared the effects of Celecoxib, Rofecoxib and Naproxen on 24 hour blood pressure. The paper found that while Rofecoxib did significantly elevate blood pressure from baseline over the 12 weeks study, Celecoxib and Naproxen did not.
In appraising this trial there are two key things to note. Firstly, the end point is 24 hour blood pressure and not a hard patient oriented outcome such as stroke or myocardial infarction. Secondly, the three comparators are all active as there is no placebo arm. The only conclusion we can arrive at from the paper is that Celecoxib is no better or worse than Naproxen in affecting 24 hour blood pressure.
Action: Prescribers should continue to follow the MHRA Advice when considering prescribing any NSAID.
- Sowers J et al. The Effects of Cyclooxygenase-2 Inhibitors and Nonsteroidal Anti-Inflammatory Therapy on 24-Hour Blood Pressure in Patients With Hypertension, Osteoarthritis, and Type 2 Diabetes Mellitus. Arch Intern Med. 2005; 165:161-168